Browse Device Recalls
39,162 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,162 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 39,162 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 10, 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... | Class I | Medline Industries, LP |
| Apr 10, 2026 | Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ2... | Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, ... | Class II | Medline Industries, LP |
| Apr 10, 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... | Class I | Medline Industries, LP |
| Apr 10, 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... | Class I | Medline Industries, LP |
| Apr 10, 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... | Class I | Medline Industries, LP |
| Apr 10, 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... | Class I | Medline Industries, LP |
| Apr 10, 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP,... | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, U... | Class I | Medline Industries, LP |
| Apr 10, 2026 | BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CA... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOL... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYS... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLO... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Produ... | Out-of-specification endotoxin result that did not meet the acceptance criteria. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLO... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLO... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIO... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYS... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-153... | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 10, 2026 | Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIO... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232... | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 10, 2026 | Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I,... | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 10, 2026 | Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-1519... | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in i... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 10, 2026 | BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOL... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIO... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 10, 2026 | BARD Dynamic Tip Steerable, Product Number 6DYNTP001; | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 9, 2026 | Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 ... | Due to nonconforming products being inadvertently distributed. | Class II | Stryker Corporation |
| Apr 8, 2026 | Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6... | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) pr... | Class II | Becton, Dickinson and Company |
| Apr 8, 2026 | Swan-Ganz Pacing Catheter, Models: D200F7; | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) pr... | Class II | Becton, Dickinson and Company |
| Apr 8, 2026 | Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) pr... | Class II | Becton, Dickinson and Company |
| Apr 8, 2026 | 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D... | Complaints have been received of systems developing loose, missing, or broken internal bolts over... | Class II | Hologic, Inc |
| Apr 8, 2026 | Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software ... | Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode,... | Class II | Medtronic Neuromodulation |
| Apr 8, 2026 | SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, S... | Complaints have been received of systems developing loose, missing, or broken internal bolts over... | Class II | Hologic, Inc |
| Apr 7, 2026 | BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use | BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Gene... | Class II | Becton Dickinson & Co. |
| Apr 7, 2026 | BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use | BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Gene... | Class II | Becton Dickinson & Co. |
| Apr 6, 2026 | QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, strepto... | Product has the potential for false positive results | Class II | Quidel Corporation |
| Apr 6, 2026 | LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xW... | Stent-assisted coiling device may due to commingling during manufacturing have dimensional noncon... | Class II | MICROVENTION INC. |
| Apr 3, 2026 | TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 4... | Due to incorrect functional length on device labeling. | Class II | Grace Medical, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.